Clinical Laboratory

A clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.

Clinical laboratories are at the forefront of the personalized medicine trend. However, they are also targets for cost-cutting measures by payers, and increased regulation by CMS and FDA, making the industry a challenging one in which to succeed.

Laboratory medicine is generally divided into two sections, each of which being subdivided into multiple units. These two sections are:

  • Anatomic pathology: Units included here are histopathology, cytopathology, and electron microscopy. Other disciplines pertaining to this section include anatomy, physiology, histology, pathology, and pathophysiology.
  • Clinical pathology, which includes:
    • Clinical Microbiology: This encompasses five different sciences. These include bacteriology, virology, parasitology, immunology, and mycology.
    • Clinical Chemistry: Units under this section include instrumental analysis of blood components, enzymology, toxicology and endocrinology.
    • Hematology: This section consists of automated and manual analysis of blood cells.
    • Genetics is also studied along with a subspecialty known as cytogenetics.
    • Reproductive biology: Semen analysis, Sperm bank and assisted reproductive technology.

Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. The international standard in use today for the accreditation of medical laboratories is ISO 15189. Under their respective approaches to laboratory licensure and accreditation, many countries have legal requirements that medical laboratories must be accredited to ISO 15189. This is not true in the United States.

In the United States, there are federal and state laws that address the licensure and accreditation of medical laboratories. Accreditation is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88, the Clinical Laboratory Improvement Amendments, also dictate testing and personnel.

In addition, many clinical laboratories have adopted quality management programs such as Six Sigma and Lean quality to improve clinical quality, reduce turnaround time, cut costs, and boost productivity. Lean and Six Sigma are both process improvement methodologies. At a very basic level, Lean is about speed and efficiency, while Six Sigma is about precision and accuracy, leading to data-driven decisions. Lean and Six Sigma methods are finding numerous applications in anatomic pathology laboratories and pathology group practices.

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CEO SUMMARY: New and more easily transmitted variants of SARS-CoV-2 are causing surges…

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PerkinElmer Says California Terminated COVID-19 Contract

ACCORDING TO A NEW SECURITIES FILING FROM PERKINELMER, the State of California served notice of termination of the company’s contract to run the beleaguered Valencia Branch Laboratory (VBL). PerkinElmer, a diagnostics firm based in Waltham, Mass., made the surprising announcement a…

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Jury Finds Elizabeth Holmes Guilty in Four of 11 Criminal Counts

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Theranos Lost $585 Mil. in 2015, Had Revenue of Just $500,000

AMONG THE BEST-KEPT SECRETS at Theranos during its glory days of 2013, 2014, and 2015—when the news media hailed now-disgraced founder and ex-CEO Elizabeth Holmes as a business genius to match Apple founder Steve Jobs—was the actual revenue the company was generating from its clinic…

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Pathologist Makes News at Elizabeth Holmes Trial

CEO SUMMARY: During the trial, a pathologist who formerly was CLIA lab director at Theranos testified about the little regard Theranos executives had for federal proficiency testing regulations labs must follow to retain their CLIA license. Another point of contention was how this p…

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Executive War College to Show New Opportunities for Labs

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Lab Briefs

DOJ Obtains $140 Mil. Settlement in Drug Testing Case Last Friday, the U.S. Department of Justice (DOJ) announced a settlement totaling $136,025,077 with multiple defendants accused of using illegal inducements to encourage physicians to re…

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NeoGenomics Acquires Inivata to Access Liquid Biopsy Technology

SOME BELIEVE THAT LIQUID BIOPSY TECHNOLOGY has the potential to develop into a Holy Grail of cancer diagnostics. Yet progress in this field has been slow. Now a recent lab acquisition may accelerate the development of clinically-useful liquid biopsies. There is keen interest in how to achieve the …

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India’s Neuberg Diagnostics Expands into U.S. Market

“Our idea is to enhance the access and affordability for next-generation techniques, meaning molecular diagnostics, genomics, pathology, digital pathology, proteomics, metabolomics, and all that. This is the spirit behind Neuberg Diagnostics. —GSK Velu, PhD, BPharm …

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Lab Briefs

University of Miami Settles Lab Qui Tam Lawsuit for $22 Million EARLIER THIS MONTH, THE FEDERAL DEPARTMENT OF JUSTICE (DOJ) announced a settlement with the University of Miami that resolves allegations that the university ordered medicall…

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